EQUIPMENT QUALIFICATION
Qualification is the documented evidence that any
equipment is installed as per approved technical specifications, operates as
per approved functional specifications and performs as per approved user
requirement specifications. The brief flow of the qualification is as
follow:
v Prior
to the equipment or instrument qualification commences any critical equipment
or instrument shall have a User Requirement Specification (URS), which is
prepared by the user department, projects / engineering department. Copy of URS
shall be distributed to all vendors identified through the purchase department.
v Based
on the acceptance / feedback from the vendors techno commercial discussions
with different vendors shall be conducted to finalise the vendor. Based on the
outcome of techno commercial meeting the purchase department shall generate
purchase order and submit to the vendor identified mutually by purchase
department and user department / projects / engineering department for
procurement.
v A design
qualification / design specifications shall be prepared based on the URS and
discussion between the vendor and user department, projects / engineering
department.
v Factory
Acceptance Test shall be performed to ensure the equipment is manufactured as required
to custom made equipment based on criticality.
v The
equipment / instrument received at the facility / site shall be taken for
commissioning and qualification as per the respective procedures.
Following is the V-Model for equipment qualification for
basic flow of any equipment qualification:
Following is the process to qualify any equipment but
based on the criticality each steps may be modified, clubbed or removed:
1.
USER
REQUIREMENT SPECIFICATION (URS)
1.1 The
URS is document which describes the basic requirements of individual aspects of
facility, items of equipment, utility and system in terms of function, capacity
/ output, operating parameters, control
systems and other cGMP / GLP requirements.
1.2 The
URS defines the functions to be carried out, the data on which the system will
operate and the operating environment. This URS shall describe all essential
requirements as described below:
Ø Basic
Information (such as Name of the Equipment / System & Suggested
Manufacturers / Suppliers
Ø Functional
Requirements ( such as Purpose of the Equipment / System, Required Capacity,
Operating Range, Operational Hours and Environment)
Ø Operational
Requirements:
·
Process Requirements
·
Material of Construction and Finish Requirements
·
Alarms, Interlocks, Safety Features, Access
Controls, etc. Requirements
Ø Others
(cGMP / GLP Requirements, connectivity to other equipment / systems etc).
Ø Documentation
Requirements (such as operational & maintenance manuals, qualification
protocols & supporting documents, drawings etc.).
1.3 The
detailed URS is need not required to be prepared for commercially available
equipment / instrument / system.
1.4 The
URS shall be reviewed by engineering department for availability and suitability
of specifications, QA shall review the URS with respective to GMP norms and
approve it.
2.
DESIGN
QUALIFICATION (DQ)
2.1 Design Qualification is made by Technical Specification and Functional Specifications. The main purpose of the DQ is to provide the documented evidence that all relevant
issues based on the requirements of process, product and the cGMP have been
considered. Design Qualification provided by the manufacturer shall be verified
for requirement of User Requirement Specifications and / or Purchase Order.
2.2 A DQ
shall detail and record the structured approach followed. The DQ shall address
the nature of the system with specifications. It shall also incorporate the
necessary design features for construction, utilities etc. The key design
specifications are identified as below:
Ø Major
components design specification includes MOC for critical components
Ø Process
control instruments / devices specifications
Ø Description
of safety features including alarms / interlocks.
Ø Required
utilities with specifications
Ø System
/ equipment engineering drawings (Mechanical / electrical).
Ø Piping
and instrumentation diagrams (P & ID).
Ø Software
/ PLC specifications including drawings, wiring diagrams etc.
3.
FACTORY
ACCEPTANCE TESTING (FAT)
3.1 FAT
is carried out only for the critical equipment. For custom made equipment /
instrument, Factory Acceptance Test may be conducted at manufacturer’s site by
inspection team comprising of representative from Technology Transfer Group /
User department and Project / Engineering department to ensure the fitness of
the entity for the intended use.
3.2 The
purpose is to ensure that all the design criteria and process requirements as
laid down in the purchase order / User Requirement specification / Design
qualification has been taken care of and when installed at the site of the
operation, the entity will perform as designed. Following shall be checked at
the time of inspection but not limited to:
Ø Equipment
/ system details
Ø Component
verification
Ø MOC
of Major components (Contact parts / Non-contact Parts)
Ø PLC /
HMI is functional
Ø Calibration
certificates
Ø Control
system
Ø Safety
features verification
Ø Functionality
of the equipment / system
Ø Documentation
3.3 The
inspection team shall finally give the clearance for dispatch of the equipment
/ instrument / system.
4.
SITE
ACCEPTANCE TESTING (FAT)
4.1 SAT
is carried out only for the critical equipment if required. The purpose is to
ensure that all the design criteria and process requirements as laid down in
the purchase order / User Requirement specification / Design qualification has
been taken care of and when installed at the site of the operation, the entity
will perform as designed. Following shall be checked at the time of inspection
but not limited to:
Ø Equipment
/ system details
Ø Component
verification
Ø MOC
of Major components (Contact parts / Non-contact Parts)
Ø PLC /
HMI is functional
Ø Calibration
certificates
Ø Control
system
Ø Safety
features verification
Ø Functionality
of the equipment / system
Ø Documentation
5.
INSTALLATION
QUALIFICATION (IQ)
5.1 Equipment
/ instrument / system shall be subjected to installation qualification to
ensure that all the key aspects of installation adhere to the User requirement
specification / design specification, manufacturer’s recommendation. IQ
protocol should include, but not limited to the following:
Ø Identification
and verification of the subjected instruments and its major components.
Ø Identification
and verification all process control instruments / measuring devices.
Ø Identification
and verification of the material of construction for major components.
Ø Identification
and verification of all supporting utilities for proper connection.
Ø Identification
and verification of all safety features, if any.
Ø Identification
of standard operating procedures for operation, cleaning and preventive
maintenance etc.
Ø Identification
and verification of all supporting documentation.
6.
OPERATIONAL
QUALIFICATION (OQ)
6.1 Equipment
/ instrument / system shall be subjected to operational qualification to ensure
that system consistently operates within its specified operational ranges. OQ
Protocol should include, but not limited to the following:
Ø Calibration
of the critical process control instruments, identified in the Installation
Qualification.
Ø Verification
of the Functional Keys; Design parameters; Safety features and interlocking,
Sequential operation & Effect of Power failure.
Ø Verification
of the relevant SOPs for their operational adequacy (such as operation,
Cleaning, Calibration and Preventive Maintenance etc.).
Ø Identification
of training needs.
Ø The
completion of a successful Operational qualification should allow the
finalization of identified Standard Operating Procedures (SOPs), Operator
training and preventative maintenance requirements.
6.2 Operational
Qualification shall be performed only after successful completion of
installation qualification (IQ).
7.
PERFORMANCE
QUALIFICATION (PQ)
7.1 Performance
Qualification shall be performed only after successful completion of
installation qualification (IQ) and operational qualification (OQ).
Note: Performance
qualification can also be performed along with operational qualification where
found appropriate and with proper justification.
7.2 Performance
Qualification shall be carried out for all the critical equipment pertaining to
manufacturing process, quality control testing activities and utilities.
7.3 This
study includes, checking of critical operating parameters with load (Placebo or
product) and any other impact shall be evaluated.
7.4 Tests
carried out during performance qualification (PQ) shall be targeted to verify
the performance requirements specified in the URS are met.
7.5 Verification
during PQ shall also be targeted to confirm the cGMP and safety regulations
were met. The PQ protocol shall define the objective of test, methodology and
acceptance criteria for each test.
7.6 Test
using production materials, qualified substitutes or simulated product proven
to have equivalent behavior under normal operating condition with commercial
batch size shall be carried out.
7.7 Test
should cover the operating range of intended process, unless documented
evidence from the development phases for controlling the operating range is available.
7.8 If
equipment found with some deficiencies, the same shall be addressed in summary
report and necessary corrective action shall be followed–up.
7.9 If
equipment fails to meet the requirements, the equipment shall be disqualified
(Rejected / Replaced). The respective protocol shall be made “Obsolete” and shall
be retained with QA.
Note: Based on the criticality and
requirement the Installation, Operational and Performance Qualification can be
done simultaneously as per the requirement.
No comments:
Post a Comment